Biocorp of France has developed the Lyoseal cap - an innovative solution for sealing vials that come with lyophilised medicines
Intended for use by pharmaceutical laboratories, the Lyoseal cap is a completely innovative patented device: it has been designed to seal a vial and its standard stopper inside a lyophiliser in one step, within a sterile environment, thus eliminating the risk of microbiological contamination.
The European Medicines Agency (EMEA), the EU's regulatory body, and the Food and Drug Administration (FDA), its US counterpart, both recommend that partially stoppered freeze-dried vials be maintained in a sterile environment until the cap has been crimped.
Lyoseal goes further by making it possible to seal all the medicine vials in the lyophiliser itself, in a Class A aseptic area, eliminating the crimping operation that is required with a conventional aluminium seal (capping), while also doing away with the re-handling process, which increases the risk of microbiological contamination of lyophilised medicines.
The Lyoseal cap offers another advantage: the top of the stopper remains sterile when the end-user removes the flip-off cap.
Besides, it is guaranteed tamper-proof, since the cap cannot be put back on once it has been removed.
This means that Lyoseal enables the proprietary drug to be clearly distinguished from a possible counterfeited copy.
Furthermore, Biocorp's device avoids the need for an additional aseptic area outside the lyophiliser, thus generating savings at production level.
The Lyoseal cap is manufactured in plastics that can be sterilised by autoclaving (+121C), yet which at the same time are resistant to a temperature of -70C, as required for freeze-drying.
Two different size models will be available: 20 and 13mm.
